(AZithromycin ThErapy for Chronic lung disease 2) (AZTEC2)
Research type
Research Study
Full title
Long term follow-up of Azithromycin Therapy for Chronic Lung Disease of Prematurity The AZTEC 2 (AZithromycin ThErapy for Chronic lung disease 2) (AZTEC2)
IRAS ID
270464
Contact name
Sailesh Kotecha
Contact email
Sponsor organisation
Velindre Cancer Centre
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
Throughout the world, every year more than 12 million babies are born prematurely, with especially those born at <32 weeks of pregnancy being at risk of developing breathing problems. The original AZTEC study is investigating 800 babies born <30 weeks of pregnancy to discover if a ten day course of azithromycin, an antibiotic, can decrease the breathing disorder called CLD (chronic lung disease of prematurity) when compared to dummy (placebo) medicine. We have shown that the microbe, Ureaplasma, can lead to development of CLD. Azithromycin is very effective against Ureaplasma, but also against lung inflammation, which we have shown to be common in premature babies who develop CLD.
I have three questions, which this study will address:
1. Does azithromycin improve the long-term respiratory and neurodevelopmental outcomes of preterm-born children at 1 and 2 years of corrected age?
2. Does azithromycin reduce the number of hospital admissions in the first and second years of life?
3. Does azithromycin improve the growth of preterm-born infants in the first and second years of life?To answer the above questions at each time point:
1. We will mail parents the (a) validated neurodevelopmental and (b) respiratory questionnaires. In addition, we will ask them for (c) information on hospital admissions and (d) growth of their babies, which are routinely collected from the red book by Health visitors and at follow up at the local neonatal units.
2. We will contact the local hospitals for data from clinic letters including a) symptoms, b) development, c) growth, d) hospital admissions, and e) medication data.
3. We will collect neurodevelopmental data from (a) the local units who often see these babies for assessing their development at two years of age; (b) obtain data from a central repository where most of the UK baby units send their data (NDAU).REC name
Wales REC 3
REC reference
19/WA/0267
Date of REC Opinion
22 Oct 2019
REC opinion
Further Information Favourable Opinion